FDA UDI
In Commercial Distribution
🇺🇸 United States
Songer® Spinal Cable System
DI: 00840298704545
·
Model: 400-211
·
Pioneer Surgical Technology, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Songer® Spinal Cable System
- Primary DI
- 00840298704545
- Version / Model
- 400-211
- Catalog Number
- 7925-021S
- Company Name
- Pioneer Surgical Technology, Inc.
- Labeler DUNS
- 793384496
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-23
- Public Version
- 3
- Public Version Date
- 2025-12-16
- Public Version Status
- Update
- Public Device Record Key
- 7990e5ca-6c13-49a0-b557-c9a501a5be74
Device Description
(6) Ø1.25mm Cable, ISOLA with Crimp, (10) Crimp, Flange
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JDQ | Cerclage, fixation | Orthopedic | 888.3010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44797 | Internal spinal fixation system cable | An implantable fixation device designed to apply a force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. The device is typically made of braided medical grade titanium (Ti) and stainless steel alloy of various lengths and designs (e.g., it may be supplied with or without attached fasteners). The cable is tightened with a tension device and is fastened or crimped at each eye-type screw. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840298704545 | GS1 | ||||
| Previous | 10846468005280 | GS1 |
Customer Contacts
- Phone
- +1(906)226-9909
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K941213 | 000 |